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Active Not Recruiting
NCT07629128
Patients With Primary Biliary Cholangitis(PBC)
Conditions: Primary Biliary Cholangitis, Liver Fibrosis, Cirrhosis, Liver, Blood Sugar; High
Sex: All
Ages: 18 Years – N/A
Enrollment: 30
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli Roma
Summary
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced stages, cirrhosis. Recent advances in the understanding of PBC pathophysiology have highlighted the central role of immune, inflammatory, and metabolic alterations in disease onset and progression.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed diagnosis of PBC (biochemical criteria, antibody positivity and/or histological examination)
* The patient is a candidate for first- or second-line PPAR agonist therapy, as clinical practice, for the treatment of PBC
* The patient requires comprehensive metabolic monitoring, as per clinical practice
* Signed the informed consent form
Exclusion Criteria:
* Patients with a prior diagnosis of diabetes mellitus currently on insulin therapy
* Patients on treatment known to significantly affect glycemic values (e.g., GLP-1 receptor agonists, SGLT2 inhibitors, systemic corticosteroids)
* Patients with a life expectancy or estimated time to liver transplantation of less than 6 months
Source: ClinicalTrials.gov (NCT07629128). StuddyBuddy aggregates publicly available trial information.